Product Code: DHR FDA class 2 21 CFR 866.5775

System, Test, Rheumatoid Factor

Immunology

The Rheumatoid Factor Test System is a diagnostic assay used to detect and quantify rheumatoid factor, an autoantibody directed against IgG, in patient serum or plasma, supporting the diagnosis of rheumatoid arthritis and other autoimmune conditions. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5775 within the Immunology specialty. The device is eligible for third-party 510(k) review.

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510(k)s

144

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DHR
Device Class: FDA class 2
Regulation Number: 866.5775
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 144 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192727	K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)	May 20, 2020	Substantially Equivalent	Kamiya Biomedical Company
K190088	QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents	Apr 17, 2019	Substantially Equivalent	Inova Diagnostics, Inc.
K182747	EliA RF IgM Immunoassay	Dec 18, 2018	Substantially Equivalent	Phadia AB
K162263	Optilite Rheumatoid Factor Kit	May 03, 2017	Substantially Equivalent	The Binding Site Group , Ltd.
K160070	Rheumatoid Factor (RF) Kit for use on SPAPLUS	Dec 07, 2016	Substantially Equivalent	The Binding Site Group , Ltd.
K143736	ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA	Sep 23, 2015	Substantially Equivalent	Immco Diagnostics, Inc.
K102673	RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM	Sep 30, 2011	Substantially Equivalent	Phadia US, Inc.
K100499	ORGENTEC RHEUMATOID FACTOR EIA	Oct 27, 2010	Substantially Equivalent	Orgentec Diagnostika GmbH
K083080	IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM	Oct 29, 2009	Substantially Equivalent	Sqi Diagnostics Systems
K071247	N LATEX RF KIT	Aug 08, 2007	Substantially Equivalent	Dade Behring, Inc.
K060201	OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.	Jun 06, 2006	Substantially Equivalent	Olympus America, Inc.
K041891	MININEPH HUMAN RHEUMATOID FACTOR KIT	Nov 05, 2004	Substantially Equivalent	The Binding Site
K041863	VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS	Sep 20, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K033802	ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM	Feb 27, 2004	Substantially Equivalent	Zeus Scientific, Inc.
K032535	MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM	Sep 10, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K024067	RHEUMATOID FACTOR (RF)	Jan 15, 2003	Substantially Equivalent	Abbott Laboratories
K020972	WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET	Sep 09, 2002	Substantially Equivalent	Wako Chemicals USA, Inc.
K021394	DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM	Jul 09, 2002	Substantially Equivalent	Diamedix Corp.
K002609	TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM	Sep 05, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K000534	COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II	Apr 05, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K993557	AUTOSTAT II RHEUMATOID FACTOR IGA ELISA	Mar 03, 2000	Substantially Equivalent	Cogent Diagnotics , Ltd.
K994338	AUTOSTAT II RHEUMATOID FACTOR IGM ELISA	Feb 03, 2000	Substantially Equivalent	Cogent Diagnotics , Ltd.
K993843	MDI RF TEST	Jan 11, 2000	Substantially Equivalent	Micro Detect, Inc.
K993304	AUTOSTAT II RHEUMATOID FACTOR IGG ELISA	Dec 06, 1999	Substantially Equivalent	Cogent Diagnotics , Ltd.
K991467	K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET	Jun 10, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K991409	K-ASSAY RHEUMATOID FACTOR	Jun 09, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K990587	ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01	Apr 07, 1999	Substantially Equivalent	Bio-Rad
K990035	RF	Mar 08, 1999	Substantially Equivalent	Abbott Laboratories
K984045	RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS	Jan 25, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K983418	THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL	Nov 18, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K983084	QUANTA LITE RF IGA ELISA	Nov 04, 1998	Substantially Equivalent	Inova Diagnostics, Inc.
K983083	QUANTA LITE RF IGG ELISA	Nov 04, 1998	Substantially Equivalent	Inova Diagnostics, Inc.
K981496	COLOR-SLIDE RF	Jun 15, 1998	Substantially Equivalent	Seradyn, Inc.
K974889	DIAMEDIX IS-RF TEST SYSTEM	Mar 06, 1998	Substantially Equivalent	Diamedix Corp.
K974370	RAPET RF	Feb 17, 1998	Substantially Equivalent	Stanbio Laboratory
K972456	RHEUMACOL RHEUMATOID FACTOR TEST	Nov 25, 1997	Substantially Equivalent	Immunostics Inc.,
K973464	QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)	Oct 22, 1997	Substantially Equivalent	Instrumentation Laboratory CO
K972220	RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT	Sep 09, 1997	Substantially Equivalent	Randox Laboratories, Ltd.
K971602	ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT	Jun 27, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K971614	QUANTA LITE RF IGM	Jun 20, 1997	Substantially Equivalent	Inova Diagnostics, Inc.
K971379	TINAQUANT RHEUMATOID FACTOR ASSAY	Jun 17, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K971788	SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR	Jun 03, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K970373	RAICHEM RHEUMATOID FACTOR SPIA	Apr 17, 1997	Substantially Equivalent	Henage Diagnostics, Inc.
K962729	HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY	Mar 07, 1997	Substantially Equivalent	Hycor Biomedical, Inc.
K962050	THERATEST EL-RFSCR	Dec 16, 1996	Substantially Equivalent	Theratest Laboratories, Inc.
K964418	N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET	Dec 13, 1996	Substantially Equivalent	Kamiya Technology Services
K964415	N-ASSAY TIA RHEUMATOID FACTOR TEST KIT	Dec 13, 1996	Substantially Equivalent	Kamiya Technology Services
K962015	RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST	Nov 25, 1996	Substantially Equivalent	Teco Diagnostics
K963048	IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT	Nov 04, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K961545	QUALITROL RF CONTROLS	Sep 24, 1996	Substantially Equivalent	Consolidated Technologies, Inc.
K962836	HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)	Sep 12, 1996	Substantially Equivalent	Hemagen Diagnostics, Inc.
K961169	RHEUMATOID FACTOR LATEX SLIDE TEST KIT	Jun 26, 1996	Substantially Equivalent	Randox Laboratories, Ltd.
K960987	LIQUICHEK RHEUMATOID FACTOR CONTROL	Jun 04, 1996	Substantially Equivalent	Bio-Rad
K961277	RF IGM ELISA TEST SYSTEM	May 08, 1996	Substantially Equivalent	Zeus Scientific, Inc.
K960703	RF-LATEX SEIKEN REAGENT SYSTEM	Apr 19, 1996	Substantially Equivalent	Globe Management Support, Inc.
K954892	HYTEC AUTOMIMMUNE KIT (RF)	Dec 26, 1995	Substantially Equivalent	Hycor Biomedical, Inc.
K955086	TEST, RHEUMATOID FACTOR	Dec 20, 1995	Substantially Equivalent	Polymedco, Inc.
K953520	OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT	Aug 24, 1995	Substantially Equivalent	Olympus America, Inc.
K953261	CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM	Aug 15, 1995	Substantially Equivalent	Shared Systems, Inc.
K941398	EL-RF/3 (IGM-IGG-IGA) KIT	Jul 28, 1995	Substantially Equivalent	Theratest Laboratories, Inc.
K942908	IGM RF EIA	Jan 20, 1995	Substantially Equivalent	Sigma Diagnostics, Inc.
K942328	N LATEX RF	Oct 20, 1994	Substantially Equivalent	Behring Diagnostics, Inc.
K942272	IGM RHEUMATOID FACTOR	Sep 26, 1994	Substantially Equivalent	Immco Diagnostics, Inc.
K933712	EL-RF TEST SYSTEM: EL-RF-IGM KIT	Jan 28, 1994	Substantially Equivalent	Theratest Laboratories, Inc.
K932437	EYE SPOT RF TEST	Aug 23, 1993	Substantially Equivalent	J & S Medical Assoc., Inc.
K926569	IMMUNO RA UNDILUTED	Apr 06, 1993	Substantially Equivalent	Immunostics Co., Inc.
K915320	RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST	Dec 07, 1992	Substantially Equivalent	Trinity Laboratories, Inc.
K924036	ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST	Dec 01, 1992	Substantially Equivalent	J.S. Medical Assoc.
K923578	LIQUICHEK RHEUMATOID FACTOR CONTROL	Oct 06, 1992	Substantially Equivalent	Bio-Rad
K923771	PULSE RF TEST	Oct 05, 1992	Substantially Equivalent	Pulse Scientific, Inc.
K922725	TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL	Oct 05, 1992	Substantially Equivalent	Simplicity Diagnostics, Inc.
K924056	ENCORE RHEUMATOID FACTOR EIA	Sep 25, 1992	Substantially Equivalent	Clark Laboratories, Inc.
K922151	WAKO AUTOKIT RF	Jul 28, 1992	Substantially Equivalent	Wako Chemicals USA, Inc.
K920753	RF STAT IGM TEST KIT	Mar 30, 1992	Substantially Equivalent	Biowhittaker Molecular Applications, Inc.
K920220	HEALTHTEST RHEUMATOID FACTOR ASSAY	Mar 13, 1992	Substantially Equivalent	Akers Research Corp.
K920124	TURBIQUANT	Mar 02, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K904310	RHEUMAGEN RF T-CONTROL	May 31, 1991	Substantially Equivalent	Biokit USA, Inc.
K910539	RHEUMAJET RF	Apr 05, 1991	Substantially Equivalent	Biokit USA, Inc.
K904498	CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST	Oct 29, 1990	Substantially Equivalent	Biotrax, Inc.
K904105	V-TREND TARGET RF TEST	Oct 15, 1990	Substantially Equivalent	Texas Immunology, Inc.
K903852	RAPITEX(R) RF NEW	Aug 30, 1990	Substantially Equivalent	Behring Diagnostics, Inc.
K902462	MODIFIED QM300 RHEUMATOID FACTOR TEST	Jun 21, 1990	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K896271	QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)	Nov 08, 1989	Substantially Equivalent	Biokit USA, Inc.
K894574	TECHNICON DPA-1 SYSTEM RF METHOD	Aug 10, 1989	Substantially Equivalent	Technicon Instruments Corp.
K892445	REAADS-RF TEST KIT-SEMIQUANTITATIVE	Jun 05, 1989	Substantially Equivalent	Biosearch Medical Products, Inc.
K892444	REAADS-RF TEST KIT-QUANTITATIVE	Jun 05, 1989	Substantially Equivalent	Biosearch Medical Products, Inc.
K884180	TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM	Feb 03, 1989	Substantially Equivalent	Unipath , Ltd.
K883538	QM300 CALIBRATOR E PACK	Sep 07, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K883536	QM300 RHEUMATOID FACTOR ANTIGEN PACK	Sep 07, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K883355	UBI MAGIWEL RF-IGM QUANTITATIVE	Sep 07, 1988	Substantially Equivalent	United Biotech, Inc.
K880164	RF CARD TEST & RF LIQUID TEST	Feb 10, 1988	Substantially Equivalent	Ampcor, Inc.
K874151	RF DIPSTICK TEST KIT	Dec 29, 1987	Substantially Equivalent	Lipogen, Inc.
K873782	REUMA TEST	Nov 27, 1987	Substantially Equivalent	Sclavo, Inc.
K873064	AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT	Nov 04, 1987	Substantially Equivalent	Amtec Diagnostics International, Inc.
K871196	RHEUMA-CHECK ENZYME IMMUNOASSAY TEST	May 06, 1987	Substantially Equivalent	Orion Diagnostica, Inc.
K871041	RF MICROASSAY	Mar 31, 1987	Substantially Equivalent	Diamedix Corp.
K863238	READS RF TEST KIT FOR IGM RHEUMATOID FACTOR	Oct 08, 1986	Substantially Equivalent	Biostar Medical Products, Inc.
K855221	SERATEST RF (HEMAGGLUTINATION) KIT	Apr 22, 1986	Substantially Equivalent	Hemagen Diagnostics, Inc.
K854222	DIESSE RF TEST KIT	Feb 06, 1986	Substantially Equivalent	Marvic Interpharma, Inc.
K854820	RA 80 EIKEN	Jan 17, 1986	Substantially Equivalent	Syn-Kit, Inc.
K853054	RF CARD TEST	Aug 01, 1985	Substantially Equivalent	Preco, Inc.
K851537	LASER RF CONTROL SERUM-QUALITY CONTROL SERUM	Jun 05, 1985	Substantially Equivalent	Behring Diagnostics, Inc.
K851099	IGM RHEUMATOID FACTOR TEST KIT	Apr 25, 1985	Substantially Equivalent	Breit Laboratories, Inc.
K850296	LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS	Apr 12, 1985	Substantially Equivalent	Behring Diagnostics, Inc.
K850373	ABBOTT RF EIA DIAGNOSTIC KIT	Mar 01, 1985	Substantially Equivalent	Abbott Laboratories
K843896	RHEUMADX LATEX AGGLUTINATION RHEUMATOID	Oct 25, 1984	Substantially Equivalent	Diagnostic Products Corp.
K841454	RF TEST KIT	Apr 25, 1984	Substantially Equivalent	Difco Laboratories, Inc.
K841146	NCS RA LATEX TEST	Apr 20, 1984	Substantially Equivalent	Ncs Diagnostics, Inc.
K840863	SERATEST RF LATEX DETERMINATION	Apr 04, 1984	Substantially Equivalent	Seragen Diagnostics, Inc.
K840005	NABI RF-Q.S. TEST	Feb 13, 1984	Substantially Equivalent	Intl. Diagnostic, Inc.
K840049	SOPHEIA MP IGM RHEUMATOID FACTOR EIA	Feb 10, 1984	Substantially Equivalent	Diagnostic Products Corp.
K834391	IMMUNO-RA	Feb 03, 1984	Substantially Equivalent	Immunostics Co., Inc.
K831941	LEAP RHEUMATOID FACTOR TEST KIT	Jul 18, 1983	Substantially Equivalent	Cooper Diagnostics, Inc.
K831597	SERO/TEX RED CELL RF TEST	Jun 30, 1983	Substantially Equivalent	Texas Immunology, Inc.
K831467	RA-CHECK	Jun 08, 1983	Substantially Equivalent	Diagnostic Technology, Inc.
K830832	RHEUMATOID FACTOR-RAPID CARD TEST #65114	Apr 18, 1983	Substantially Equivalent	Emd Chemicals, Inc.
K830611	RA SCREENING TEST	Mar 24, 1983	Substantially Equivalent	Tago, Inc.
K822905	LATEST RF KIT FOR RHEUMATOID FACTOR	Oct 18, 1982	Substantially Equivalent	Fisher Scientific Co., LLC
K821941	RHEUMATOID FACTOR REFERENCE PREPARA.	Aug 27, 1982	Substantially Equivalent	Armkel, LLC
K821319	SERO/TEX RF TEST	May 21, 1982	Substantially Equivalent	Texas Immunology, Inc.
K813309	RA-80 POSITIVE CONTROL	Dec 17, 1981	Substantially Equivalent	Sun-Kit
K812972	RA LATEX TEST	Nov 06, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K812968	FIAX RHEUMATOID FACTOR TEST KIT	Nov 06, 1981	Substantially Equivalent	Intl. Diagnostic Technology
K812882	RHEUMATEX	Oct 26, 1981	Substantially Equivalent	Armkel, LLC
K811375	BI-RA SLIDE TEST	Jun 12, 1981	Substantially Equivalent	Biologics Intl., Inc.
K810404	RHEUMATOID FACTORS REFERENCE SERUM	Mar 11, 1981	Substantially Equivalent	Calbiochem-Behring Corp.
K810306	RHEUMATOID FACTOR REAGENT TEST KIT	Mar 11, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K810221	SCRIPPSERA THEUMATOID FACTOR REFER. CNTL	Feb 09, 1981	Substantially Equivalent	Scripps-Miles, Inc.
K810141	SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT	Feb 09, 1981	Substantially Equivalent	Scripps-Miles, Inc.
K802448	RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.	Jan 05, 1981	Substantially Equivalent	Syn-Kit, Inc.
K802688	RHEUMATOID FACTOR TEST SYSTEMS	Dec 18, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K801961	RF-II TEST KIT	Oct 10, 1980	Substantially Equivalent	Immuno-Diagnostic Products, Inc.
K800268	AUTOMATED RHEMATOID FACTOR TEST (ARFT)	Feb 21, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K792697	NORMAL GLOBULIN REAGENT	Jan 24, 1980	Substantially Equivalent	Meridian Diagnostics, Inc.
K792695	ANTI-GLOBULIN CONTROL	Jan 24, 1980	Substantially Equivalent	Meridian Diagnostics, Inc.
K791507	AGGLUTINOTEST-RHEUMATOID ARTHRITIS	Dec 31, 1979	Substantially Equivalent	Volu Sol Medical Industries
K792061	CORDIA RF	Nov 27, 1979	Substantially Equivalent	Cordis Corp.
K790351	RHEUMATELL	Mar 15, 1979	Substantially Equivalent	Central Biological Co.
K790012	RHEUMOGEN TEST SYSTEM	Jan 26, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K771940	QUANTROLS RF	Nov 02, 1977	Substantially Equivalent	Organon, Inc.
K771410	RHEUMANOSTICON R	Sep 02, 1977	Substantially Equivalent	Organon, Inc.
K771552	LAS-R RHEUMATOID FACTOR TEST	Aug 30, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K760043	TEST, RHEUM. ARTH., CARD (MACRO-VUE)	Aug 03, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760036	TEST, LATEX SLIDE, RHEUMATOID FACTOR	Aug 03, 1976	Substantially Equivalent	Gamma Biologicals, Inc.